FDA 510(k) Applications Submitted by Whitney Torning
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100044 |
01/08/2010 |
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY |
BLACKSTONE |
| K980385 |
02/02/1998 |
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES |
DATASCOPE CORP. |
| K150267 |
02/04/2015 |
QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators |
MAQUET CARDIOPULMONARY AG |
| K980780 |
03/02/1998 |
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES |
DATASCOPE CORP. |
| K101199 |
04/29/2010 |
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, |
MAQUET CRITICAL CARE AB |
| K051724 |
06/27/2005 |
ACUMEN IMAGE GUIDED SURGICAL SYSTEM |
EBI, L.P. |
| K112114 |
07/25/2011 |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 |
MAQUET CRITICAL CARE AB |
| K102182 |
08/03/2010 |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 |
MAQUET CRITICAL CARE AB |
| K973007 |
08/13/1997 |
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER |
DATASCOPE CORP. |
| K132829 |
09/09/2013 |
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS |
MAQUET CARDIOPULMONARY AG |
| K123149 |
10/05/2012 |
SERVO-I VENTILATOR SYSTEM |
MAQUET CRITICAL CARE AB |
| K133265 |
10/23/2013 |
QUADROX-IR ADULT AND SMALL ADULT |
MAQUET CARDIOPULMONARY AG |
| K994157 |
12/09/1999 |
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 |
DATASCOPE CORP. |
| K113679 |
12/14/2011 |
LUCEA LED SURGICAL LIGHT SYSTEM |
MAQUET SAS |
| K080394 |
02/13/2008 |
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K080407 |
02/14/2008 |
BLACKSTONE SFS PARALLEL ROD CONNECTORS |
BLACKSTONE MEDICAL, INC. |
| K081177 |
04/25/2008 |
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K081684 |
06/17/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K081849 |
06/30/2008 |
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
BLACKSTONE MEDICAL, INC. |
| K082235 |
08/07/2008 |
BLACKSTONE PILLAR XL PEEK SPACERS |
BLACKSTONE MEDICAL, INC. |
| K092624 |
08/26/2009 |
FIREBIRD SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K082797 |
09/23/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
| K955417 |
11/27/1995 |
VITAL PAK |
VITAL SIGNS, INC. |
| K073420 |
12/05/2007 |
BLACKSTONE ASCENT MULTIAXIAL SCREWS |
BLACKSTONE MEDICAL, INC. |
| K073654 |
12/26/2007 |
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR |
BLACKSTONE MEDICAL, INC. |
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